DR -HOS
One hand and wrist support. Made of cloth, the device is worn on the body
10manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Henan (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Yangzhou Sensport Healthcare Supplies Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 27 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Shenzhen Jiding Electronic Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Pranash (Tianjin) Technology Development Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 5 |
| Zhengzhou Magique Huaer Biotech Co., Ltd. | Zhengzhou | Henan | Manufacturer | 3 |
| Jiangxi Zhicheng Health Technology Co., Ltd. | Yingtan | Jiangxi | Manufacturer | 1 |
| Suichang Xiangdong Industry and Trading Co., Ltd. | Lishui | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Guangzhou Xinbo Electronic Co., Ltd., China |
|---|---|
| FDA product code | MNE |
| Device type | Orthosis, Moldable, Supportive, Skin Protective |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3475 |
| Establishment | Contract manufacturer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-09-01 |
| Record revised | 2022-08-30 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NN-WR-Blue | In distribution | |
| NN-SH-Blue | In distribution | |
| NN-AN-Blue | In distribution | |
| NN-CA-Blue | In distribution | |
| NN-EL-Blue | In distribution | |
| NN-LB-Black | In distribution | |
| NN-KN-Blue | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Guardian Supporter | BM Korea Co., Ltd. | 12 |
| Orpyx Sensory Insoles | Orpyx Medical Technologies Inc. | 3 |
| Orpyx SI sensory insoles | Orpyx Medical Technologies Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.